Interoperability Proving Ground (IPG) submissions within the ONC Tech Lab are submitted by healthcare, technology and development organizations that are invested in Health IT and Interoperability and want to share, learn and collaborate with similar stakeholders in the US, and around the world.

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LEAP 2019 - San Diego Regional Health Information Exchange

This project is focused on Standardization and Implementation of Scalable HL7® FHIR® Consent Resource by creating a FHIR-based platform that simplifies consent management and ensures interoperable services for the following four use cases: (1) privacy consent, (2) medical treatment consent, (3) research consent, and (4) advance care directives. 

The research team includes individuals from Health Information Exchange (HIE) operator San Diego Health Connect and Cognitive Medical Systems, Inc., and leverages the collective strengths of these organizations to meet ONC’s research objectives by creating a common FHIR-based authorization framework capable of management and enforcement of patient consent as well as organizational and jurisdictional policies. We will also review additional privacy- and security-related standards to ensure they support the current FHIR Consent Resource. 

This work will build on previously successful FHIR Consent Resource demonstrations at HL7, ONC Pilots, and sponsored HIMSS Interoperability Showcase demonstrations where the SDHC Team has already addressed three of the four use cases. 

Following a research phase to study the standard, current implementations, and the related standards and business requirements, the team will develop a proposed set of improvements and will build APIs to enable the consent use cases which have important implications for patient-centered care, informed consent, and shared decision-making. The API will be tested with each of the LEAP use cases in live exchanges at the SDHC HIE. The SDHC Team will also build a FHIR Consent Implementation Guide (IG) including examples derived from these use cases as well as additional implementation, legal, and security concerns raised within the project testbed. The IG will come with a package of open-source prototypes and documentation that assist partners in deploying the framework as a RESTful service and address the consent workflow.
Start Date
Projected End Date
Project Tags
  • Consent
  • FHIR
  • Interoperability
Project Point of Contact:
Project Results
The LEAP Project has completed the first version of a Consent Decision Service (LEAP CDS). This service enables clients to ask about the patient consent decision applicable to a specific workflow contexts, such as processing a request for exchange of a patient's medical record. The Consent Decision Service responds with a permit/deny decision as well as applicable obligations. The LEAP CDS  relies on Consent Stores, FHIR servers where patient consents are stored and can be looked up. Currently the LEAP CDS supports query interfaces based on XACML and Clinical Decision Support API.

The LEAP Project team has successfully tested this service in enforcing patient consent in an HL7v2 exchange use-case and is currently working on integration and testing this service in an eHealth Exchange scenario.